Aesculap B BRAUN microspeed uni Instrucciones Para El Trato Y Cuidado

Aesculap Power Systems
Care advisory
microspeed® uni motors and motor cables
Pflegehinweise
microspeed® uni Motoren und Motorkabel
Consignes d'entretien
Moteurs et câbles moteur microspeed® uni
Instrucciones para el trato y cuidado
Motores y cables de motor microspeed® uni
Avvertenze per la cura
Motori e cavi motore microspeed® uni
Conselhos de conservação
Motores e cabos de motor microspeed® uni
Onderhoudsinstructies
microspeed® uni-motoren en motorkabels
Underhållsanvisningar
microspeed® uni motorer och motorkablar
Уходу
Моторны и кабель мотора microspeed® uni
Aesculap AG & Co. KG
Am Aesculap-Platz
78532 Tuttlingen
Phone +49 7461 95-0
Fax +49 7461 95-2600
www.aesculap.de
TA-Nr. 011532 03/06
CE marking according to directive 93/42/EEC
CE-Kennzeichnung gemäß Richtlinie 93/42/EWG
Marquage CE conforme à la directive 93/42/CEE
Identificación CE en conformidad con la directriz 93/42/CEE
Marchio CE conforme alla direttiva 93/42/CEE
Simbolo CE, em conformeidade com a Directiva 93/42/CEE
CE-certificering conform richtlijn 93/42/EEG
CE-märkning i enlighet med direktiv 93/42/EEG
Маркировка СЕ согласно директиве 93/42/ЕЭС
Technical alterations reserved
Technische Änderungen vorbehalten
Sous réserve de modifications techniques
Sujeto a modificaciones técnicas
Con riserva di modifiche tecniche
Salvo alterações técnicas
Technische wijzigingen voorbehouden
Med reservation för eventuella tekniska ändringar
Мы оставляем за собой право вносить технические
изменения
microspeed® uni motors and
motor cables
Intended use
The microspeed® uni motors are used with a microspeed® uni motor cable
connected to microspeed® uni control unit GD670 or microspeed® arthro con-
trol unit GD665. The microspeed® uni motors are high-precision, high-perfor-
mance power units. Consequently, careful processing and care are essential
for achieving a long service life.
Overview
Designation
microspeed® uni motor cable for foot control
microspeed® uni motor cable with hand control
microspeed® uni mini 100 motor, mini-Line coupling
microspeed® uni Hi 150 motor, Hi-Line coupling
microspeed® uni Hi 100 motor,Hi-Line coupling
microspeed® uni micro 150 motor, micro-Line coupling
microspeed® uni micro 100 motor, micro-Line coupling
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on order of a physician!
Read, follow and keep the instructions for use.
Use the product only in accordance with its intended use, see Intended
use.
Clean the new product either manually or mechanically prior to the ini-
tial sterilization.
Store any new or unused products in a dry, clean and safe place.
Prior to each use, inspect the product for: loose, bent, broken, cracked,
worn, or fractured components.
Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
Replace any damaged components immediately with original spare
parts.
Do not use products that are in open or damaged sterile packaging.
Safe operation
Note
This care advisory does not replace the instructions for use of the microspeed®
uni motor system. For operating the microspeed® uni motors and motor cables,
always observe the instructions for use of the microspeed® uni motor system
(TA022089) or of the microspeed® arthro motor system (TA022156).
Processing
Note
Observe all relevant national regulations and standards with regard to pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible
variants of CJD, observe the relevant national regulations concerning the
reprocessing of the products.
Note
Up-to-date information on reprocessing can be found on the Aesculap Extra-
net at www.aesculap-extra.net.
Preparations
Prior to first mechanical cleaning/disinfection: Mount ECCOS® storage
device GB578R (for GD674, GD676, GD677, GD678, GD679) and GB689R
(for GD672, GD673) in a suitable basket tray (e.g. JF214R).
Mount the storage devices in such a way that the cables can be coiled in
a circle with a bending radius of not less than 10 cm. Do not kink the
cables.
Separate the motor from the motor cable prior to reprocessing.
Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
Remove all attached components such as adapters, tubes, etc.
Reprocess the product immediately after use.
Do not clean the product by ultrasound treatment under any circum-
stances.
Put away the product in dry condition.
Cleaning/Disinfecting
Damage to the product due to inappropriate clean-
ing/disinfecting agents and/or excessive tempera-
tures!
Only use cleaning and disinfecting agents that
do not affect softeners (e.g. silicone), according
CAUTION
to the manufacturers' instructions for use.
Do not exceed the maximum allowable cleaning
temperature of 55 °C.
Use cleaning/disinfecting agents that are suitable for the product.
Always follow the manufacturer's instructions regarding concentration,
temperature and exposure time.
Avoid encrustation of residues/proteins (e.g. caused by aldehyde/alco-
hol).
Only use bactericidal, fungicidal and virucidal disinfecting agents.
Preferably use thermal disinfecting processes.
Mechanical cleaning/disinfecting
Pre-cleaning
Thoroughly pre-rinse under running water.
Cleaning
Place the product in its proper position in the ECCOS® storage device
immediately after use.
Process the product in a single-chamber cleaning/disinfecting machine
without ultrasound treatment. Follow the instructions provided by the
manufacturer of the machine.
Carry out the processing cycle:
– Use an appropriate neutral, alkaline or mildly alkaline cleaning/disin-
fecting agent according to the manufacturer's instructions.
– Do not exceed the maximum cleaning temperature of 55 °C.
– Wash the product for at least 3 min.
– Neutralize if necessary.
– Carry out intermediate rinse for at least 1 min.
– Carry out intensive final rinse with distilled, demineralized or fully
desalinated water.
– For thermal disinfection: Rinse with distilled, demineralized or fully
desalinated water for 5 min, at 93 °C.
– Complete the program with a drying phase of at least 10 min at a
temperature of not more than 120 °C.
After completion of the mechanical cleaning/disinfecting cycle, inspect
for visible debris all surfaces and places that are difficult to access.
Clean manually if necessary.
Manual cleaning/disinfecting
Use an appropriate neutral, alkaline or mildly alkaline cleaning/disinfect-
ing agent according to the manufacturer's instructions.
Do not clean the product by ultrasound treatment under any circum-
stances.
Do not immerse the product in any fluid. Allow any fluid that has pene-
trated the device to run out immediately.
Clean all surfaces with a soft nylon brush and a suitable cleaning/disin-
fecting agent.
Remove encrusted debris with a soft nylon brush. Do not use harsh
cleaning agents or metal brushes.
Thoroughly brush and rinse surfaces under running water.
Carry out intensive final rinse with distilled, demineralized or fully
desalinated water.
Inspect for visible debris all surfaces and places that are difficult to
access. If necessary, repeat the cleaning/disinfection process.
Dry the product with a lint-free cloth.
Make certain that lumens and channels are dried, too.
Control, care and inspection
Allow the product to cool down to room temperature.
Inspect the product after each cleaning and disinfecting cycle to be sure
it is clean, functional and undamaged and does not show atypical run-
ning noises, overheating or excessive vibrations.
Set aside the product if it is damaged.
After cleaning and before sterilization, always lubricate the motor with
oil spray STERILIT® HI GA536:
– Fully insert the spray can adapter on the nipple at the rear end of the
motor.
Art. no.
– Hold the spray can in a vertical position and push down the spray
nozzle valve until oil extrudes at the front end of the handpiece
GD672
coupling of the motor.
– Wipe away any excess oil.
GD673
Packaging
GD674
Always follow the instructions for use of the respective storage devices
(e.g. instructions for use TA009721 for the Aesculap ECCOS® storage sys-
GD676
tem).
Insert the product in its proper position in the ECCOS® storage device, or
GD677
put it on a tray in such a way that the product is protected against dam-
age. Observe the weight limit for each tray/container.
GD678
Package trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
GD679
Make certain that the product is wrapped in such a way that recontam-
ination of the product in the period between reprocessing and reuse will
be prevented.
Sterilization method and parameters
Damage to motor cables GD672 and GD673 caused
by sterilization in sterilizers of small volume! Hot
wall surfaces (>150 °C) in the sterilizer can damage
the motor cable!
Protect the motor cable (e.g. by wrapping it in
CAUTION
a cloth).
Sterilize with steam, taking note of the following:
The sterilization has to be carried out according to a validated steam
sterilization procedure (e.g. in a sterilizer according to EN 285/ANSI/
AAMI/ISO 11134-1993, ANSI/AAMI ST 46-1993 and validated according
to EN 554/ISO 13683). In the fractioned vacuum process, sterilization
must be carried out using the 134 °C/2 bar program with a minimum
holding time of 5 minutes.
Note
Steam sterilization at 134 °C for a holding time of 18 min can adversely affect
the service life of the product.
Make certain that the motor cables are not kinked or coiled up too
tightly. The coil radius has to be larger than 10 cm.
When sterilizing several products at the same time in one steam steril-
izer: Make sure that the maximum allowable load capacity of the steam
sterilizer, as specified by the manufacturer, is not exceeded.
Sterilization for the US market
• Sterilization of the device may be accomplished by steam.
• Aesculap does not recommend the device be sterilized by "Flash" or
chemical sterilization.
• Surgical instruments may also be placed within an Aesculap rigid steril-
ization container (sterile container) for processing under generally
accepted hospital in-use conditions.
The recommended sterilization parameters are as follows:
Sterilization
Temp.
method
Pre-vacuum 270—
275 °F
WARNING for the US market
If this device is/was used in a patient with, or suspected of having
Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must
be destroyed due to the inability to reprocess or sterilize to eliminate the
risk of cross-contamination!
Storage
Store processed products under conditions as germ-free as possible, in a
dry, dark, cool and dust-protected room.
Maintenance
To ensure reliable operation, Aesculap recommends that maintenance be per-
formed after 300 reprocessing cycles, at least once per year.
For services to this end, please contact your national B. Braun/Aesculap
agency, see Technical Service.
Technical Service
For service, maintenance or repairs, please contact your national B. Braun/
Aesculap agency.
Modifications carried out on medical technical equipment may result in loss
of guarantee/warranty rights and forfeiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 7461 95-2700
Fax: +49 7461 16-2887
E-mail: ats@aesculap.de
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood, MO 63042
Aesculap Repair Hotline
Phone: +1 800 214-3392
Fax: +1 314 895-4420
Other service addresses can be obtained from the address indicated above.
Distributor in the US/Contact in Canada for
product information and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
Minimum exposure time
In a sterile container
Wrapped
system
4 min 4 min